Peripheral vascular disease (PVD) MedDRA version: 14.0 Level: LLT Classification code 10034634 Term: Peripheral vascular disease NOS System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Cialis* 10mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
Other descriptive name: TADALAFIL
Concentration unit: mg milligram(
Sponsors
Guy's & St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Male aged 18-80 years with ED and Peripheral Vascular Disease • Symptomatic claudication confirmed by previous ultrasound studies • Provision of written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Contraindication to PDE-5 inhibitor • Inability to undertake an exercise tolerance test (ETT). • Patients taking nitrates • Unable to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the benefit of daily dosing with the PDE 5 inhibitor Cialis to improve symptoms of intermittent claudication in patients with erectile dysfunction and peripheral vascular disease (PVD). ;Secondary Objective: n/a;Primary end point(s): Total number of minutes/seconds on the exercise treadmill; time (minutes/seconds) to first report of leg pain when undertaking the Exercise Tolerance Test. | — |
Countries
United Kingdom
Outcome results
None listed